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NCT06728332: ESTeeM

An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems

Completed Last updated 25 November 2025
What this trial tests

trial testing No study intervention in Sleep Disturbances Associated With Menopause in 750 participants. Completed in 27 October 2025.

Timeline
6 December 2024
Primary endpoint
29 August 2025
27 October 2025

Quick facts

Lead sponsorBayer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment750
Start date6 December 2024
Primary completion29 August 2025
Estimated completion27 October 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Bayer — full company profile →

Who can join

Adults 40 to 65, female only, with Sleep Disturbances Associated With Menopause. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an observational study in which data from women with sleep disturbances and vasomotor symptoms, also known as hot flashes, associated with menopause (SDM) are collected and studied. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, such as frequent waking up at night, are a common symptom (clinical sign) and a major worry associated with menopause that affects women's quality of life. The participants will continue to take their regular treatment for their SDM as agreed with their doctors. These are called "standard of care" treatments. Because both patients and doctors don't know much about SDM, women are often treated with sleep medicines that can lead to addiction and cause side effects. This study will help us to learn more about how much menopause-related sleep problems affect a woman's overall health and well-being. We also want to find out how women are currently being treated or treat themselves for these sleep problems, so we can figure out if there's a need for new treatments that focus specifically on menopause-related sleep issues To do this, researchers will collect information on: * the number of times a woman wakes up during the night and the total time she is awake after she first falls asleep * the time when a woman goes to bed and when she wakes up in the morning * how long it takes for a woman to fall asleep after going to bed * changes in sleep problem questionnaire scores to assess how these problems affect a woman's quality of life The data will come from combining all the electronic health record databases, patient related questionnaires, and data from smartwatches that the women will wear on their wrists. The data will be collected between November 2024 to May 2025. In this study, researchers will combine all the electronic data during a 28-day follow-up period. No visits or tests are required as part of this study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06728332.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing